Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF/PMPF) and PMCF/PMPF Studies

Post-Market Surveillance

For any MD (including IVDMDs) placed on the market, made available on the market or put into service, manufacturers shall design, establish, document, apply, maintain and implement a post-market surveillance system according to the risk and the type of device* concerned.

The collection and analysis of relevant data on the quality, performance and safety of the MD are based on a post-market surveillance plan.

These data are actively and systematically collected throughout the lifetime of the MD.

Input data include complaints, vigilance data & trend analyses, sales data, etc.

The plan should include the methodology used to identify any statistically significant increase in the frequency or severity of incidents and the observation period. The establishment of trend curves can be a challenge for manufacturers.

For Class I MDs and Class A and B IVDMDs, the summary of analysis results and conclusions concerning the collected post-market surveillance data are set out in a post-market surveillance report. The report is updated as necessary, integrated into the technical documentation and made available to the competent authority on request.

For other classes of MDs, the summary of analysis results and conclusions concerning the collected post-market surveillance data are set out in a periodic safety update report (PSUR) integrated into the technical documentation and made available to the notified body and on request to the competent authorities.  For Class III devices, implantable devices, and Class D IVDMDs, manufacturers shall submit the PSUR via Eudamed and must for the time being follow the transitional measures (see MDCG 2021-1).

Post-market surveillance is an essential tool to ensure the performance and safety of devices.

It helps:

• Update the benefit-risk ratio and improve the risk analysis
• Update design and manufacturing information
• Update clinical performance data
• Update the summary of safety and clinical performance (SSCP/SSP), the package insert and the label
• Identify the need for preventive/corrective actions
• Improve the usability, performance and safety of the MD
• Contribute to the post-market surveillance of other devices
• Identify trends

Post-market clinical follow-up

Post-market clinical follow-up (PMCF/PMPF) is an integral part of post-market surveillance.  PMCF is a proactive process of collecting and evaluating clinical/performance data resulting from the use of a CE-marked MD placed on the market or put into service as intended. PMCF is a continuous process of updating the clinical evaluation.

The following MDCG guides:

• MDCG-2020-7: PMCF Plan Template, and
• MDCG-2020-8: PMCF Evaluation Report Template

present all the data needed to conduct PMCF.

Like post-market monitoring, PMCF aims to:

• Confirm the safety and performance of the IVDMD.
  • Identify unknown adverse events (AEs) and monitor known AEs and CIs.
  • Identify and analyse emerging risks.
  • Verify the acceptability of the benefit-risk ratio on an ongoing basis.
  • Identify errors in use or off-label use.

Our intervention

The arrival of the MDR and IVDR has significantly strengthened the requirements for post-market surveillance. New deliverables are required and are part of the technical documentation to be submitted to the notified body.

In this context, where demand for compliance is strong and urgent, the Efor Group is providing its customers/MD/IVDMD manufacturers with its expertise and a methodical approach, thanks to a team of specialised experts who can manage post-market monitoring from A to Z, from the implementation of the PMS plan to the writing of the report, while engaging in collaborative work based on exchange.

*and accessories